Driving the Business of Science

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, discusses the challenges of drug development and shortages with Sarah Norring, Ph.D., Co‑founder and CEO of Plenitude Pharma Inc. Sarah highlights the critical need to address drug shortages and discontinuations, emphasizing the importance of having multiple manufacturers for essential medicines. She shares her background in medical science and her company's focus on bringing back critical drugs, particularly in women's health and oncology. Sarah mentions the FDA's expedited review process for off-patent drugs on the FDA’s drug shortage list, and her aims to bring one to two products to market within the first three years. The conversation also touches on the challenges of fundraising in this niche pharma sector.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group,  interviews Mitchell Bayer, Managing Principal of Arlen Consulting Group, about the evolution of the life science industry and the role of CROs. Mitch discusses his 24-year career, starting at Medidata, where he spearheaded the ASPire to Win™ CRO partner program, which grew to 16 partners by 2009. He emphasizes the importance of integrating technology with CROs to enhance competitiveness and efficiency. Mitch highlights the shift from paper-based trials to electronic data capture (EDC) and the potential of AI in streamlining clinical trials. He also discusses the importance of technology that integrates seamlessly with existing systems and reduces site burden.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group,  interviews Nicholas Dirks, President and CEO of The New York Academy of Sciences. Nick emphasizes the importance of federal funding for basic research and the need for international collaboration while highlighting the impact of the pandemic and the current administration on scientific research, funding cuts, and the exodus of international researchers. He also explains why the Academy’s efforts to connect scientists from around the world in various fields, including AI and biomedical research, is a crucially important aspect of its overall mission to drive scientific innovation and address global challenges. Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, speaks with Nathalie Riebel, CEO and founder of Oncospire Consultants, a consultancy specializing in small biotechs. Nathalie points to the $80 billion pharma outsourcing market and the performance and quality challenges that accompany it. The data consistently shows that this massive transfer of work is plagued by delays, quality failures, sponsor dissatisfaction, and governance gaps that remain stubbornly unresolved. The conversation emphasizes the need for small biotechs to effectively manage vendors and drive results. Oncospire’s "Clinical Momentum Method" helps companies to streamline processes and reduce oversight time. Oncospire provides packages for CRO selection, gap assessment (Critical Path Visibility Assessment), and operational improvements, aiming to save small biotechs time and money in the management of their full-service CROs and vendors.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group,  speaks with Dr. Peter Reinhart, Ph.D., Director of the Institute for Applied Life Sciences (IALS) at UMass Amherst. Dr. Reinhart shares his journey from academia to founding startups, including developing therapeutics for Alzheimer's and Parkinson's. IALS, funded by a $95 million award from the Massachusetts Life Science Center, provides translational research facilities and supports startup companies. The institute offers unique resources like large lab spaces, advanced equipment, and a collaboration with the Isenberg School of Management to foster entrepreneurship. Reinhart emphasizes the cost advantages and growing capacity for startups in Western Massachusetts.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group,  and Jenna Rouse, Global Head of Clinical Operations at Simulations Plus discuss the benefits of simulation-based clinical research training, which allows sites to practice protocol-specific tasks without risking patient safety. Jenna shares a case study where simulation training improved procedural accuracy from 14% to 86% over six months. The discussion emphasizes the importance of effective training in clinical trials to ensure compliance and patient safety.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group,  speaks with Ezekiel Kelley, VP of Engagement and Growth at the Frederick Innovation and Technology Center (FITCI), about the importance of incubators in driving innovation. FITCI, a business incubator in Frederick, Maryland, supports life science startups by providing resources, office and lab space, and connections to state and federal resources. FITCI has grown from 40 to nearly 120 companies in two years, many collaborating with the FDA, NIH, and Fort Detrick. The center offers shared lab space, accelerated courses, and an advisory board of experienced founders. FITCI's success is attributed to its nonprofit status, cost-effective operations, and strategic partnerships.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group,  and Jeremy Bromberg, an independent operations advisor with a background in life sciences and pharmaceutical market research, share insights on improving business operations. The conversation highlights the importance of compliance, effective pricing strategies, and organizational structure. Jeremy stresses the need for specialized knowledge in life sciences, the significance of aligning employee skills with company needs, and the critical role of management in balancing sales, execution, and logistics. Jeremy also outlines the steps to build a successful professional services firm, starting with understanding the firm's vision and goals. Keith and Jeremy both emphasize the importance of adhering to regulations and continuous learning to succeed in the life science industry.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, and Roy Strunin, Director of Marketing at BrandUp Strategy, discuss the intersection of business, science, and marketing in the pharmaceutical, biotech, and medical device industries. Keith highlights the collaboration between Court Square Group, a managed service firm specializing in IT infrastructure for life science organizations, and BrandUp Strategy, a full-service marketing agency supporting life science service providers. Roy shares his background in life science marketing and the founding of BrandUp Strategy. Together, they explore the differences between technology companies and life science firms, emphasizing the critical role of regulatory compliance. The conversation also examines how thought leadership and digital marketing work together to build awareness, establish credibility, and spark meaningful conversations that drive growth in life science organizations.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, interviews Joseph Jerry, Ph.D., a researcher at UMass Amherst and Science Director of Pioneer Valley Life Sciences Institute (PVLSI). Dr. Jerry explains PVLSI's role in translational research, particularly in breast cancer, and the creation of the breast research registry and HistoSpring. They discuss the importance of diverse patient populations, the use of human tissues for research, and the potential of organoids. The conversation highlights the collaboration between academia, healthcare, and industry in advancing scientific research.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group,  and Dave Kwajewski, Executive Director of Business Development at Corealis Pharma, discuss the challenges and strategies in selling science. Dave, with 22.5 years in sales, emphasizes the importance of understanding scientific processes and the evolution of sales techniques, from traditional trade shows to AI-driven interactions. He highlights the need for companies to focus on their strengths, especially in early drug development, and advises leaders to hire smartly and understand market realities. Keith and David agree on the value of networking and personal interactions in building trust and closing deals.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group, discusses the intersection of science and business in drug development with Dr. Joseph Geraci, Founder, Chief Scientific and Technical Officer of NetraMark. Dr. Geraci, with a background in mathematics and AI, focuses on understanding patient populations and improving clinical trials. He explains how NetraMark's AI technology can analyze small, complex data sets to identify treatment and placebo responder subpopulations and improve drug efficacy. Dr. Geraci emphasizes the potential of adaptive trials and the importance of personalized medicine. He predicts the future of AI in clinical trials will involve modular AI systems integrating pattern-finding and language interfaces to enhance drug development and patient care.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, hosted by Keith Parent, CEO of Court Square Group, guest Mark Connell, Co-Founder and President of SLBST Pharma, discusses the company’s mission to repurpose hydroxychloroquine to treat endometriosis, a condition affecting 7 million American women. Despite limited current therapies, SLBST Pharma aims to leverage the drug’s proven efficacy in reducing lesions by 60%. Challenges include navigating the complexities of drug development, fundraising, and staying agile amidst setbacks. Connell emphasizes the importance of tenacity, community engagement, and the ultimate goal of alleviating pain and improving lives.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, and guest Michael Joseph, CEO of Technium, discuss their collaboration on global networks for the life science industry. Technium specializes in connecting data from the edge to the cloud, offering secure network services and leveraging AI advancements. Their recent projects include assisting Moderna with their global network during the COVID pandemic and designing a network for Frontier Scientific Solutions to revolutionize the clinical supply chain. Both firms emphasized the importance of security, reliability, and the collegial approach to solving complex problems in the field of life sciences.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group, discusses the complexities of the life science industry and introduces Chris Matheus from the Global Life Science Alliance (GLSA). Chris, with 30 years in clinical research, co-founded GLSA to connect smaller companies with business development opportunities and experts. The conversation emphasizes the importance of collaboration and networking, highlighting GLSA's role in facilitating connections for regulatory consulting, pre-clinical, and clinical trial management, and innovative solutions such as AI. Chris and Keith also talk about "Friends of Chris Matheus" (FOCM), a networking club he founded to foster industry connections. The conversation underscores the need for efficient, cost-effective solutions to support drug development and innovation.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, discusses with Mario Perkins, President of Triam Ltd, the intersection of IT infrastructure and data management in the life sciences. Triam specializes in data management and analytics, particularly in healthcare and life sciences, and has recently partnered with Court Square. They discuss the shift from legacy systems like SAS to open-source tools like Python and R, disruptive technologies like Altair SLC and RapidMiner that can bridge and enhance this shift, the importance of data quality, and the benefits of AI and machine learning in drug development and clinical trials. They also touch on the transition from on-premise to cloud-based solutions and the role of hybrid approaches in managing large data sets.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, interviews Christa Bleyleben, Managing Partner at MassGlobal Partners. Christa's firm helps international early and growth-stage companies navigate the U.S. market, providing programs for C-level executives to learn business practices, networking, and cultural differences. They work with companies from various sectors, including life sciences, robotics, and AI, and have supported firms from countries like Korea, Japan, and Northern Ireland. Christa emphasizes the importance of understanding U.S. market dynamics, the rigorous due diligence process for investors, and the value of mentorship and networking.  Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, speaks with Arielle Smith, President of Life Sciences at Event Cadence about their event technology platform which supports medical conferences and Key Opinion Leader (KOL) engagement. They discuss the importance of in-person interactions and the evolving landscape of HCP (Healthcare Provider) engagement. Event Cadence's Ensemble software facilitates omni-channel engagement, adapting to different company needs, from small startups to large pharma companies. The conversation emphasizes the value of personal connections and the future potential of KOLs reaching out to pharma companies.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, interviews Sara Tylosky, CEO of Farmacon Global, about the Latin American market for clinical trials. Farmacon Global, a strategic partner with a network of physicians, focuses on rare diseases, oncology, and immunology in Latin America. Sara highlights the region's diversity, cost savings, and fast recruitment, noting that Latin America represents 0.7% of global phase 1 studies but has a population of more than 660 million and 30+ qualified sites. She addresses misconceptions about slow recruitment and regulatory issues, emphasizing the region's alignment with international guidelines and the potential for collaboration with CROs. Farmacon Global aims to expand its phase 1 research opportunities and educate biotechs on the region's benefits.Interested in learning more about clinical trials in Latin America?  WEBINAR: Early Clinical Trials in LATAM: A Sustainable Data Strategy September 18, 2025. 12 Noon ESTWEBINAR registration via RARE DIEM ALLIANCE Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, hosts Samantha Trotman Burman to discuss mental health across the life science spectrum. Samantha, CEO and co-founder of StoryCatch Partners, shares her journey in mental health advocacy, driven by personal experiences and the need for better support and data collection. She emphasizes the importance of integrating mental and physical health data, using real-world examples like knee replacements and heart surgery. Samantha highlights the role of caregivers and the impact of mental health on them. She also discusses the company's acquisition of EmpiraMed, its B Corp status, and the potential for comprehensive mental health registries to drive systemic change.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of Driving the Business of Science, Keith Parent, CEO of Court Square Group discusses pharmacovigilance compliance for small and mid-sized sponsors with Betty Cory, President of Regxia. Betty explains that pharmacovigilance monitors drug safety in real-world use, often revealing unforeseen adverse effects. Small companies struggle with managing vast amounts of data, necessitating electronic systems. Betty emphasizes the importance of finding partners who understand small businesses' needs and can provide tailored solutions. Court Square Group's platform, RegDocs365™, is highlighted as a fit-for-purpose solution. Betty also shares her background and the philosophy of Regxia, which focuses on becoming an integral part of clients' operations.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of Driving the Business of Science, Keith Parent, CEO of Court Square Group, talks with Catherine Lunardi, CEO of GENAIZ, about the challenges and opportunities of implementing Artificial Intelligence (AI) in life science companies. Catherine explains her company's Intelligent Automation solutions, particularly their data orchestration platform. They discuss their partnership, which began at an economic development forum in Massachusetts. Catherine shares her background in pharmaceuticals and the inspiration behind GENAIZ, emphasizing the importance of AI in streamlining data management. They highlight successful projects involving a cross-referencing tool for large document volumes and introduce GENAIZ's semantic search engine for literature reviews. GENAIZ offers a powerful Data Orchestration platform purpose-built for the life sciences industry. We empower Pharmaceutical Sponsors, CDMO’s, CROs, Hospitals, Clinical Trials, and Academic Labs to make their data “talk” fast using advanced, Intelligent Automation solutions. Our Intelligent Automated solutions break down silos across Regulatory, Quality, Laboratory, and R&D functions—streamlining processes, enhancing compliance, and accelerating decision-making.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group, discusses De-Risking the Early Phase Clinical Trial Supply Chain with Jim Kernan, CEO of PRONAV Clinical, a 40-year veteran of the pharmaceutical industry. Their conversation focuses on early-phase clinical supply chains, highlighting the shift from linear to multi-nodal supply chains in biotech. Jim explains the role of the Qualified Person (QP) in ensuring GMP compliance and data management, emphasizing the importance of secure data handling. They also discuss the complexities of cold chain logistics, particularly the challenges of maintaining -80°C temperatures for biologics, and the validation of labeling processes for ultra-low temperature products. Jim mentions the Clinical Bridge initiative to share knowledge and experiences with emerging biotech and pharma companies.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of Driving the Business of Science, Elevating Life Science Meetings & Events, Keith Parent, CEO of Court Square Group, discusses with Sam Ali, co-founder of Precision Evolution Global, the importance of attending and participating in industry events. Effective industry events aimed at decision-makers in pharma, biotech, and CROs, covering clinical trials, drug discovery, and pharma supply chains, connect key stakeholders who might otherwise struggle to find each other. As Sam explains, traditional conference models often fail to facilitate meaningful connections that extend beyond the event itself.  Their company was founded specifically to address this gap by creating events that attract decision-makers and elevate conversations beyond the venue. Post-COVID, in-person events have seen increased attendance and impact.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group, discusses the business aspects of drug development with James Blackwell, Ph.D., MBA, President of Windshire Group. They explore the importance of quality in life science, emphasizing the need for a holistic approach beyond compliance. Blackwell highlights the significance of modality-agnostic strategies, the impact of AI on efficiency, and the necessity of a simple yet effective quality system. He shares insights on managing compliance, the importance of senior leadership, and the potential cost savings from effective quality systems, citing an example where a challenging, but well-executed investigation saved AbbVie ~$8.5 billion by avoiding a delay in the launch of Humira. They also discuss the critical role of consultants in improving quality and operational excellence. Key TakeawaysExplore how AI can be leveraged to improve quality and efficiency in GMP operations.Assess your organization's quality culture and ensure senior leadership is fully aligned on the importance of quality.Review your organization's change control processes to prevent issues like the lead contamination example discussed.Evaluate your organization's response to regulatory observations and ensure a systemic approach to addressing root causes, not just a checklist approach.Consider bringing in external quality expertise to help assess and improve the organization's quality systems, if needed.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of Driving the Business of Science, Stakeholder Engagement: CROs, Vendors, and Sites, Keith Parent, CEO of Court Square Group, discusses the complexities of stakeholder engagement in the life science industry with Kimberly Guedes, VP of Clinical Operations at Intensity Pharmaceuticals. Keith and Kim explore the challenges facing small biotechs when partnering with large CROs, emphasizing the need for fit for purpose, cost-effective solutions like RegDocs365™. Kim discusses the importance of selecting the right CROs and vendors, especially for niche therapeutic areas like CNS. Keith and Kim also discuss the high costs of clinical trials, the necessity of careful planning, and the impact of global regulatory differences. Additionally, Kim shares her involvement with the Alzheimer's Association and the importance of support for caregivers and patients.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group, hosts Shelley Amster on the "Driving the Business of Science" podcast. Shelley, with over 45 years in women's health, discusses her extensive experience in mentoring startups and connecting them with strategic partners and investors. She highlights the challenges faced by small biotech companies, particularly in women's health, and the importance of mentorship and collaboration. Shelley shares perspectives from her role as an Entrepreneur in Residence, helping Israeli companies establish a presence in the U.S. She emphasizes the need for startups to understand the business aspects of their technology and the value of warm introductions and strategic partnerships.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group, discusses with Kevin Bittorf, a partner at SCxCMC Solutions, about the role of CMC (Chemistry, Manufacturing, and Controls) in the pharmaceutical industry. Kevin explains that CMC involves the science and business of manufacturing, emphasizing the importance of continuous improvement to reduce costs and enhance quality. SCxCMC, founded two years ago, provides consulting services to small and medium-sized companies, integrating expertise in pharmaceutical development, process chemistry, formulation development, regulatory affairs, quality assurance, supply chain, and packaging. Kevin highlights the significance of AI in predicting manufacturing issues and the benefits of continuous manufacturing over traditional batch processes. He also mentions upcoming conferences on compaction simulation, continuous manufacturing, and advancing drug development.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Discover how artificial intelligence is transforming the life sciences industry in this insightful episode of the Driving the Business Science Podcast. Host Keith Parent, CEO of Court Square Group and RegDocs365, is joined by Bryan Reynolds, CEO of Docxonomy, to discuss practical strategies for developing and implementing AI in organizations of all sizes. Drawing on decades of experience in unstructured data management and AI, Bryan shares actionable insights into overcoming common challenges, such as protecting sensitive corporate data, streamlining processes, and maximizing ROI.This conversation highlights how AI can revolutionize workflows, accelerate drug development timelines, and reduce manual effort in clinical and regulatory environments—all while keeping humans at the center of critical decision-making. Whether you're leading a startup or a large enterprise, this episode provides a roadmap for integrating AI effectively without getting overwhelmed by technical complexity.Key Topics:•How life sciences companies can safely adopt AI solutions.•Practical steps to develop an AI strategy, starting small and scaling.•Using AI to automate repetitive tasks like document creation and regulatory submissions.•Ensuring security and maintaining “human in the loop” for oversight.•The benefits of partnering with AI experts to drive innovation.What You'll Learn:•Strategies to safeguard intellectual property while using AI.•How to identify and optimize manual processes with AI.•The role of AI in compressing drug development timelines and enhancing efficiency.•Tips for navigating the complexities of AI adoption in the life sciences sector.Tune in to gain a fresh perspective on how AI can unlock new opportunities and help your organization thrive in a rapidly evolving industry!Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group and RegDocs365, discusses the importance of vendor management in life science with Kalyan Obalampalli (KO), CEO of ClinAI. KO shares his experience in managing $100 million in vendor contracts and the challenges of using Excel for RFPs and vendor comparisons. He highlights the benefits of ClinAI's platform, which streamlines vendor selection and management, providing analytics and data-driven decision-making. KO emphasizes the need for fit-for-purpose vendor selection, the importance of clear templates, and the potential of AI in predicting costs and ensuring fair vendor payments.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.